Status:
COMPLETED
A Prebiotic Agave Derivated Metlin & Metlos in Infant Formula
Lead Sponsor:
National Institute of Pediatrics, Mexico
Collaborating Sponsors:
Nekutli S.A. de C.V.
Conditions:
Healthy Term Babies
Eligibility:
All Genders
15-30 years
Phase:
PHASE3
Brief Summary
Objectives: To evaluate the safety; efficacy; bone mineral metabolism \& immunity changes of the use of Metlin \& Metlos added to the Infant Formula Study Design: Randomized, double blind, clinical, c...
Eligibility Criteria
Inclusion
- Healthy term babies (37 to 42 weeks of gestationl age)
- Age 15 ± 7 days at admission
- Birth weight \> 2,490 g.
- Negative history of formula intolerance (only randomized babies)
- Signed Informed Consent
Exclusion
- Clinical evidence of chronic cardiac, respiratory, gastrointestinal, hematological or metabolic disease.
- Maternal medical history of diabetes (gestational diabetes was acceptable if the infant's birth weight was at or below the percentile 95; or 4153 g or 9 lbs 3 oz for girls or 4340 g or 9 lbs 9 oz for boys
- Tuberculosis, immunologic deficiency, infection disease or perinatal infections known to cause adverse effects in the fetus
- Participation in other study
- Inability of the father/mother or legal tutor to reed or comprehend the informed consent and the symtoms report diary, or
- The infant was part of multiple labor (twins, triplets, etc.)
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01251783
Start Date
February 1 2010
End Date
October 1 2010
Last Update
December 2 2010
Active Locations (1)
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1
National Pediatric Institute
Mexico City, Mexico City, Mexico, 04530